Trial · NCT03702270
The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
NCT03702270, Not applicable, Completed, Vanderbilt University Medical Center; results first posted 2024-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal. Trials, record NCT03702270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03702270
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
- NCT number
- NCT03702270
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,052 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Penicillin Allergy
- Interventions
- Penicillin Allergic Risk Stratification Best Practice Alert
- First posted
- 2018-10-11
- Last updated
- 2024-12-18
- Results first posted
- 2024-10-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Penicillin Allergy Label Removal | Hospital discharge at approximately 4 days after admission | The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section. |
| Secondary | Adverse Events (in Particular, Reported Allergic Events) | Hospital discharge at approximately 4 days after admission | The percentage of penicillin allergic patients challenged with amoxicillin who reported adverse events |
| Secondary | Communication About Penicillin Allergy in Discharge Summary | Hospital discharge at approximately 4 days after admission | The percentage of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge. |
| Secondary | Antibiotic Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | The number of changes or new starts of penicillin or cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization" |
| Secondary | Durability of Penicillin Allergy Label Removal | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | The percentage of penicillin allergic patients whose penicillin allergy labels were removed at discharge whose labels are not reentered into the chart. |
| Secondary | Receipt of Risk Stratification Tool Assessment | Hospital discharge at approximately 4 days after admission | Number of patients with a penicillin allergy label who received a risk assessment. |
| Secondary | Time to Penicillin Allergy Label Return | From 3-18 months of follow up | For those patients who underwent a penicillin allergy label removal and it returns, we will compare the date the allergy label returned with the date it was removed |
| Secondary | Penicillin Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization" |
| Secondary | Cephalosporin Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | The number of changes or new starts of cephalosporin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event, this will be looked at as "Same hospitalization" as the challenge or "Subsequent Utilization" |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Penicillin Allergy Label Removal | Hospital discharge at approximately 4 days after admission | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Events (in Particular, Reported Allergic Events) | Hospital discharge at approximately 4 days after admission | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Communication About Penicillin Allergy in Discharge Summary | Hospital discharge at approximately 4 days after admission | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Antibiotic Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Durability of Penicillin Allergy Label Removal | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Receipt of Risk Stratification Tool Assessment | Hospital discharge at approximately 4 days after admission | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Penicillin Allergy Label Return | From 3-18 months of follow up | Intervention arm had 40 patients whose labels did not return. The control had 27 patients whose labels did not return. | days | MEDIAN |
| SECONDARY | Penicillin Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cephalosporin Utilization by Patients | Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Penicillin Allergy Label Removal | Penicillin Allergic Floor Patients- Experimental | 45 | Participants | ||
| Penicillin Allergy Label Removal | Penicillin Allergic Floor Patients- Control | 31 | Participants | ||
| Adverse Events (in Particular, Reported Allergic Events) | Penicillin Allergic Floor Patients Who Received Amoxicillin Challenge - Experimental | 0 | Participants | ||
| Adverse Events (in Particular, Reported Allergic Events) | Penicillin Allergic Floor Patients Who Received Amoxicillin Challenge - Control | 0 | Participants | ||
| Communication About Penicillin Allergy in Discharge Summary | Patient Communication About Allergy Label Removal- Experimental | Yes | 21 | Participants | |
| Communication About Penicillin Allergy in Discharge Summary | Patient Communication About Allergy Label Removal- Control | Yes | 14 | Participants | |
| Communication About Penicillin Allergy in Discharge Summary | Patient Communication About Allergy Label Removal- Experimental | No | 5 | Participants | |
| Communication About Penicillin Allergy in Discharge Summary | Patient Communication About Allergy Label Removal- Control | No | 2 | Participants | |
| Communication About Penicillin Allergy in Discharge Summary | Patient Communication About Allergy Label Removal- Experimental | Missing | 0 | Participants | |
| Communication About Penicillin Allergy in Discharge Summary | Patient Communication About Allergy Label Removal- Control | Missing | 4 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Control | STARTED | Sequence A | 17 | 1 |
| Control | STARTED | Sequence B | 31 | 1 |
| Control | STARTED | Sequence C | 51 | 1 |
| Control | STARTED | Sequence D | 27 | 1 |
| Control | STARTED | Sequence E | 53 | 1 |
| Control | STARTED | Sequence F | 65 | 1 |
| Control | STARTED | Sequence G | 97 | 1 |
| Control | STARTED | Sequence H | 87 | 1 |
| Control | STARTED | Sequence I | 125 | 1 |
| Control | STARTED | Sequence J | 179 | 1 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Penicillin Allergic Floor Patients- Experimental | 0 | 1,018 |
| Total, all-cause mortality | Penicillin Allergic Floor Patients- Control | 0 | 1,034 |
| Total, other adverse events | Penicillin Allergic Floor Patients- Experimental | 0 | 1,018 |
| Total, other adverse events | Penicillin Allergic Floor Patients- Control | 0 | 1,034 |
| Total, serious adverse events | Penicillin Allergic Floor Patients- Experimental | 0 | 1,018 |
| Total, serious adverse events | Penicillin Allergic Floor Patients- Control | 0 | 1,034 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Penicillin Allergic Floor Patients- Experimental vs Penicillin Allergic Floor Patients- Control: Receipt of Risk Stratification Tool Assessment | Trial comparisons |
Penicillin Allergic Floor Patients Who Received Amoxicillin Challenge - Experimental vs Penicillin Allergic Floor Patients Who Received Amoxicillin Challenge - Control: Adverse Events (in Particular, Reported Allergic Events) | Trial comparisons |
| Penicillin Allergic Floor Patients- Experimental vs Penicillin Allergic Floor Patients- Control: Penicillin Allergy Label Removal | Trial comparisons |
| Penicillin Allergic Floor Patients- Experimental vs Penicillin Allergic Floor Patients- Control: deaths from any cause | Trial comparisons |
| Penicillin Allergic Floor Patients- Experimental vs Penicillin Allergic Floor Patients- Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03702270
GET https://conductscience.org/api/trials/v1/NCT03702270/results?page=2